Patient Counseling Information; Directions For Use - BIOTRONIK SMALL (S) Mode D'emploi

Post-implant Precautions
• Exercise care when crossing a newly deployed stent with an intra-
vascular ultrasound (IVUS) catheter, a coronary guide wire, a
balloon catheter, or any other device to avoid disrupting the stent
placement, apposition, coating, or stent geometry.
• Refer to the "MRI Safety Information" section for the stent's MRI
compatibility information.
Potential Adverse Events/Complications
Potential adverse events associated with PTCA and stent placement
include:
• Cardiac events: MI or ischemia, abrupt closure of a coronary artery,
restenosis of a treated artery (greater than 50% obstruction),
cardiogenic shock, angina, tamponade, perforation or dissection
of coronary artery or aorta, cardiac perforation, emergency cardiac
surgery, pericardial effusion, and aneurysm formation.
• Arrhythmic events: ventricular tachycardia, ventricular fibrillation,
atrial fibrillation, and bradycardia.
• Stent system events: failure to deliver the stent to the intended site,
stent dislodgement from the delivery system, stent misplacement,
stent deformation, stent embolization, stent thrombosis or
occlusion, stent fracture, stent migration, inadequate apposition or
compression of stent/s, inflation difficulties, rupture or pinhole of
the delivery system balloon, deflation difficulties, withdrawal diffi-
culties, and embolization of catheter material.
• Respiratory events: acute pulmonary edema, congestive heart
failure, and respiratory insufficiency or failure.
• Vascular events: access site hematoma, hypotension/hypertension,
pseudoaneurysm, arteriovenous fistula formation, retroperitoneal
hematoma, vessel dissection or perforation, restenosis, thrombosis
or occlusion, vasospasm, peripheral ischemia, dissection and distal
embolization (air, tissue debris and thrombus).
• Neurologic events: permanent (stroke) or reversible (TIA) neuro-
logic event, femoral nerve injury, and peripheral nerve injury.
• Bleeding events: access site bleeding or hemorrhage, hemorrhage
requiring transfusion or other treatment.
• Allergic reactions to contrast media, antiplatelets, anticoagulants,
amorphous silicon carbide, L-605 cobalt chromium alloy, PLLA
polymer matrix, sirolimus or sirolimus derivatives.
• Death.
• Infection and sepsis.
Furthermore, all procedure-related adverse events as described in
the national and international guidelines of the respective medical
associations apply.
Potential adverse events related to oral administration of sirolimus
include, but are not limited to, abnormal liver function tests, anemia,
arthralgia, diarrhea, hypercholesterolemia, hypersensitivity (including
anaphylactic/anaphylactoid type reactions), hypertriglyceridemia,
hypokalemia, infections, interstitial lung disease, thrombocytopenia,
leukopenia, lymphoma, and other malignancies.
Drug Interactions
Drug interaction studies have not been performed. Sirolimus is metab-
olized by CYP3A4. Strong inhibitors of CYP3A4 (e.g. ketoconazole) may
cause increased sirolimus exposure to levels associated with systemic
effects, especially if multiple stents are deployed. Systemic exposure
of sirolimus should also be taken into consideration if the patient is
treated concomitantly with systemic immunosuppressive therapy.
While no specific data is available, drugs like tacrolimus, which act
through the same binding protein (FKBP), may interfere with the
efficacy of sirolimus.
Use in Special Populations
The safety and effectiveness of the Orsiro Mission have not yet been
established in the following patient population:
• Patients with unresolved thrombus at the lesion site.
• Patients with unprotected lesions located in the left main coronary
artery.
• Patients with tortuous vessels that may impair stent placement in
the region of the obstruction or proximal to the lesion.
• Patients with recent acute myocardial infarction where there is
evidence of thrombus or poor flow.
• Patients with brachytherapy treatment of the target lesion.
• Pregnant or lactating women or men intending to father children:
there are no adequate and well-controlled studies for these
patient groups. Effective contraception should be initiated before
implanting an Orsiro Mission stent and for 12 weeks after implan-
tation. The Orsiro Mission stent should be used during pregnancy
only if the benefit outweighs the risk to the embryo or fetus.
• Pediatric use for patients below the age of 18 years.
Orsiro_Mission_IFU_Version_A.indd 7
Patient Selection & Individualization of
Treatment
Judicious selection of patients according to the intended use is
necessary since the use of this device carries the associated risks of
complications listed in the "Potential Adverse Events/Complications"
section. The risks and benefit should be considered for each patient
before using Orsiro Mission. Patient selection factors to be assessed
should include a judgment regarding the risk of long-term antiplatelet
therapy (see the "Pre- and Post-procedure Antiplatelet Therapy
Recommendations" section). Special consideration should be given to
those patients with recently active gastritis or peptic ulcer disease and
patients with a high risk of bleeding in which anticoagulation therapy
would be contraindicated.
It is very important that the patient is compliant with the post-pro-
cedure antiplatelet recommendation. Premature discontinuation
of prescribed antiplatelet medication can result in a higher risk of
thrombosis, MI, or death. Prior to PCI, if a surgical or dental procedure
is anticipated that requires early discontinuation of antiplatelet
therapy, the interventionalist and patient should carefully consider
whether the DES and its associated recommended antiplatelet
therapy is the appropriate PCI choice. Following PCI, should a surgical
or dental procedure be recommended, the risk and benefits of the
procedure should be weighed against the possible risk associated with
premature discontinuation of antiplatelet therapy.
Patients who require premature discontinuation of antiplatelet
therapy secondary to significant bleeding should be monitored
carefully for cardiac events, and once stabilized, have their anti-
platelet therapy restarted as soon as possible per the discretion of
their treating physicians.
Patient comorbidities that may increase the risk of poor results or
emergency referral for bypass surgery (i.e. renal failure and severe
obesity) should be reviewed. A review of the vessel location, reference
vessel size, lesion length, qualitative target lesion characteristics, and
the amount of myocardium in jeopardy from acute or subacute throm-
bosis must also be considered.
Thrombosis following stent implantation is affected by several
baseline angiographic and procedural factors. These include vessel
diameter less than 3 mm, intra-procedural thrombus, and dissection
following stent implantation. Inpatients who have undergone coronary
stenting, the persistence of thrombus or dissection should be
considered a marker for subsequent thrombotic occlusion. Following
PCI, the patients should be monitored very carefully during the first
month after stent implantation.
Pre- and Post-procedure Antiplatelet
Therapy Recommendations
Antiplatelet/anticoagulation medication should be used in combi-
nation with Orsiro Mission. Physicians should use the information
from the current sirolimus eluting stent literature and national and
international guidelines on PCI concerning the selection, dosage,
duration, and combination of different antithrombotic drugs. Specific
needs and the risk profile of individual patients may influence the anti-
platelet/anticoagulation regime to be used.

Patient Counseling Information

In addition to counseling the patient about the procedure, stent, and
applicable post-procedural information (e.g. risks/benefits, follow-up
visits, medication, and healthy lifestyle changes), advise the patient to:
• Always carry the Patient Implant Card.
• Register the stent and the conditions under which it can be scanned
safely with the MedicAlert Foundation (www.medicalert.org) or
equivalent organization.

Directions for Use

Patient Preparation and Stent System
Selection
1. Prepare the patient and vascular access site for a PCI procedure
according to the institution's standard clinical practice.
2. Pre-dilate the lesion using a recommended balloon diameter that
is 0.5 mm smaller than the reference vessel diameter and the
length equal to or longer than the target lesion length.
3. Select a stent size which is equal to or longer than the lesion length
and an inner diameter according to the reference vessel diameter
of the target lesion. Refer to the product label for further infor-
mation on the stent crossing profile dimensions.
Stent System Preparation
4. Check and ensure that the outer packaging is not damaged or
opened prior to use. Open the outer packaging and remove the
pouch.
5. Inspect the pouch and ensure that there is no damage to the sterile
barrier before proceeding. Open the pouch.
6. Exercise care when pulling out the stent system from the
protection ring.
7. Remove the protector by pulling on the distal end.
8. Examine the stent system for any damages prior to use. Visually
check that the stent crimping is uniform, has no protruding struts
and for the centering on the balloon. Verify that the stent is posi-
tioned between the proximal and distal delivery system balloon
markers. DO NOT use if any defects are noted.
Flushing of the Guide Wire Lumen
9. Connect a syringe containing heparinized normal saline to an
appropriately-sized flushing needle. Carefully apply the flushing
needle to the distal tip of the delivery system and flush the guide
wire lumen until fluid exits at the guide wire exit point.
10. Remove the syringe and the flushing needle.
11. Leave the prepared stent system at ambient pressure.
Insertion and Stent Positioning
12. Attach a rotating hemostatic valve to the luer port of the guiding
catheter positioned within the vasculature.
13. Position the guide wire under angiographic guidance in accordance
with PCI techniques.
14. Thread the distal tip of the delivery system onto the proximal
portion of the guide wire while maintaining the guide wire position
across the target lesion.
15. Open the rotating hemostatic valve completely to allow for easy
passage of the stent.
16. Carefully insert the stent system through the rotating hemostatic
valve.
17. Advance the stent system through the guiding catheter using
fluoroscopic guidance to determine when the delivery system tip
approaches the distal tip of the guiding catheter. The shaft exit
markers on the hypotube may be used to approximate when the
stent system has reached the distal end of the guiding catheter.
18. Carefully advance the stent system into the coronary artery over
the guide wire while maintaining a stable guiding catheter seating
and a stable guide wire placement across the target lesion.
19. Position the stent within the lesion using the balloon's radiopaque
markers on the delivery system as reference points. If any resis-
tance is felt or the lesion cannot be reached or crossed, do not
apply force, stop the procedure and refer to the instructions under
the "Removal of an Unexpanded Stent" subsection.
20. Verify the stent position using angiographic guidance to assure
an adequate coverage of the lesion including the proximal and
distal margins. If the position of the stent is not optimal, carefully
reposition or remove the stent in accordance with the instruc-
tions under the "Removal of an Unexpanded Stent" subsection.
Expansion of the stent should not be undertaken if the stent is not
properly positioned within the target lesion segment of the vessel.
21. Tighten the rotating hemostatic valve.
Remove Air from the Delivery System
22. Connect a three-way stopcock to the luer port on the hub of the
delivery system.
23. Prepare and remove air from a 20 ml capacity inflation device
according to the manufacturer s recommendations and instruc-
tions.
24. Attach the inflation device containing 3 ml of balloon inflation
medium to the three-way stopcock.
25. Open the three-way stopcock to create an open fluid path between
the delivery system and the inflation device.
26. Draw a vacuum for at least 30 seconds until the air is completely
removed and there are no air bubbles present in the delivery
system's inflation lumen.
27. Close the three-way stopcock so that the fluid path to the delivery
system is closed and remove all the air from the inflation device
through the three-way stopcock.
28. Repeat steps 25-27 if necessary to ensure that the air contained in
the delivery system is removed and to prevent an uneven expansion
of the stent.
29. Open the fluid path of the three-way stopcock and avoid allowing
air back into the delivery system.
30. Set the system on neutral for the next procedural steps.
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